Positron Emission Tomography in Predicting Response in Patients Who Are Undergoing Treatment With Pemetrexed Disodium and Cisplatin With or Without Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227539
• Other study ID #: 6228
• Secondary ID: P30CA015704UWCC-
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2005
• Last updated: January 6, 2014
• Start date: July 2005

Study information

• Verified date: January 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before, during, and after chemotherapy) may help doctors predict a patient's response to treatment and help plan the best treatment. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well PET works in predicting response in patients who are undergoing treatment with pemetrexed disodium and cisplatin with or without surgery for stage I, stage II, or stage III non-small cell lung cancer.

Description:

OBJECTIVES:

Primary

• Determine the effectiveness of fludeoxyglucose F 18 positron emission tomography in predicting radiological and pathological response in patients treated with pemetrexed disodium and cisplatin with or without surgery for stage IB-IIIB non-small cell lung cancer (NSCLC).

Secondary

• Determine the safety of cisplatin and pemetrexed disodium in these patients.

• Determine the radiographic response rate, duration of response, and time to progression in patients treated with cisplatin and pemetrexed disodium.

OUTLINE: This is a multicenter study.

• Fludeoxyglucose F 18 (18FDG) positron emission tomography (PET) imaging: All patients undergo positron emission tomography (PET) imaging of the head, neck, thorax, abdomen, and pelvis. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed by 45 minutes of rest. PET imaging is done over 1 hour and 8 minutes. Patients undergo PET imaging at three points during the study: 4 weeks prior to treatment, after the first cycle of treatment, and after 3 courses of chemotherapy. Some patients then undergo surgical resection of the tumor.

• Chemotherapy: Patients receive cisplatin IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

• Stage IB, II, IIIA, or IIIB (T4, N0-1) disease

• Staging must have been performed 4 weeks prior to study entry with a CT scan of chest, upper abdomen, and fludeoxyglucose F 18 (^18FDG) positron emission tomography (PET) scan

• Mediastinal evaluation and staging based on combination of CT scan and FDG-PET results

• If N1 or N2 nodes are found by FDG-PET or CT scan, metastases must be ruled out by brain MRI

• Measurable and resectable disease

• T4 lesions must be resectable

• Eligible for curative surgery

• No malignant pleural effusion

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count = 1,250/mm^3

• Platelet count = 100,000/mm^3

Hepatic

• Bilirubin = 1.5 times upper limit of normal (ULN)

• AST and ALT = 3.0 times ULN

Renal

• Creatinine clearance = 45 mL/min

Pulmonary

• Adequate pulmonary reserve to undergo surgery

• Predicted FEV_1 > 0.8 L after resection

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

• Able to take corticosteroids

• Able to take folic acid or vitamin B_12 supplements

• No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cervical cancer

• No concurrent serious or uncontrolled disorder that would preclude study participation

• No type I diabetes mellitus

• Type II diabetes mellitus allowed if glucose is 80-150 mg/dL

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunotherapy

• No concurrent prophylactic filgrastim (G-CSF)

• No concurrent thrombopoiesis-stimulating agents

Chemotherapy

• At least 5 years since prior chemotherapy

Endocrine therapy

• No concurrent anticancer hormonal therapy

Radiotherapy

• No prior radiotherapy to the chest

• No concurrent curative or palliative radiotherapy

Surgery

• Not specified

Other

• At least 30 days since prior non-FDA-approved or investigational agents

• At least 5 days since prior aspirin or other nonsteroidal anti-inflammatory agents (8 days for long-acting agents [e.g., piroxicam])

• No other concurrent anticancer therapy

• No other concurrent investigational agents

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• cisplatin

• pemetrexed disodium

Procedure:
• adjuvant therapy

• therapeutic conventional surgery

Radiation:
• fludeoxyglucose F 18

Locations

Country	Name	City	State
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	University of Washington School of Medicine	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positron emission tomography as a predictor of response measured by the decrease in standard uptake variable (SUV) after 1 course of therapy		Between days 18 and 22 prior to second chemotherapy infusion	No
Secondary	Safety of neoadjuvant chemotherapy		Up to 4 weeks after last dose of chemotherapy	Yes
Secondary	Efficacy of neoadjuvant chemotherapy as measured by radiologic response rate		Up to 4 weeks after last dose of chemotherapy	No